Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride 10mg to Reduct Edema

Congestive Heart Failure Clinical Trial

Official title: Safety and Efficacy of the Combination of Furosemide 40 mg + Amiloride Hydrochloride 10 mg in the Reduction of Edema of Cardiac Origin in Patients With Congestive Heart Failure Functional Class II (NYHA)

Status Terminated

Clinical Trial Summary

The study consists in two treatment groups, one group will receive Diurisa® (furosemide 40 mg + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®)

Clinical Trial Description

General Purpose

1. To comparatively evaluate the tolerability and efficacy of a fixed combination of furosemide (40 mg) and amiloride (10 mg) compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA)

Specific Purposes

1. To evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)

2. To evaluate the efficacy of the fixed combination of furosemide and amiloride in reducing edema of the LLLL, as compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA). ;

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

• NCT number: NCT01210365
• Study type: Interventional
• Source: Eurofarma Laboratorios S.A.
• Status: Terminated
• Phase: Phase 3
• Start date: January 1, 2011
• Completion date: March 2013